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510(k) Data Aggregation
(189 days)
The Diode Laser Hair Removal Machine is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type IVI), including tanned skin.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The proposed device, Diode Laser Hair Removal Machine, is a surgical device. It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch.
The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black); in addition, the treatment can also be applied to different parts of the body.
The provided text is a 510(k) summary for a Diode Laser Hair Removal Machine. This document outlines the rationale for establishing substantial equivalence to a predicate device, focusing on non-clinical performance and safety data rather than a detailed study evaluating specific acceptance criteria for AI performance or clinical outcomes directly.
Therefore, many of the requested details regarding acceptance criteria, study design, expert involvement, and ground truth establishment (especially pertaining to AI/ML device performance or human reader improvement) are not present in this document. This document describes a medical device, but it is not an AI/ML device, and thus the acceptance criteria and study description won't align with questions about AI performance, human-in-the-loop studies, or extensive clinical trials as typically seen for AI-driven diagnostic tools.
Here's a breakdown of what can be extracted and what is missing based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present "acceptance criteria" in the traditional sense of a specific performance threshold (e.g., accuracy > X%). Instead, it demonstrates through non-clinical testing that the device meets safety and performance standards relevant to a laser hair removal machine by comparing it to a predicate device and showing compliance with specific technical standards (e.g., IEC standards, ISO for biocompatibility).
The "performance" is more about compliance with technical specifications and safety standards. The table "Table 1 Comparison of Technology Characteristics" (Page 7) serves as the primary comparison point.
| Item | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Product Code | Same as predicate (GEX) | GEX |
| Regulation Number | Same as predicate (21 CFR 878.4810) | 21 CFR 878.4810 |
| Intended Use | Substantially equivalent to predicate | Intended for hair removal/permanent hair reduction on all skin types (I-VI), including tanned skin, with permanent hair reduction defined as long-term stable reduction measured at 6, 9, 12 months post-treatment. |
| Configuration | Substantially equivalent (Main Unit, Handpiece, Foot Control) | Main Unit, Handpiece, Foot Control |
| Laser Type | Same as predicate (Diode Laser) | Diode Laser |
| Laser Classification | Same as predicate (Class IV) | Class IV |
| Laser Wavelength | Same as predicate (808nm) | 808nm |
| Spot Size | Not raising safety/effectiveness issues despite difference | $12 \times 20mm=2.4cm^2$ (Predicate: $1.44 cm^2$) |
| Power Density (Fluency) | Not affecting substantial equivalence despite difference | 0.96~70J/cm² (Predicate: 1-100J/cm²) |
| Output (Irradiance) | Range covered by predicate | 20.8-208.3W/cm² (Predicate: 14-360W/cm2) |
| Frequency | Range covered by predicate | 1-10Hz (Predicate: 1-20 Hz) |
| Pulse Duration | Range covered by predicate | 50 ~ 400ms (Predicate: 10~400ms) |
| Power Supply | Substantially equivalent | AC110V-240V/50-60Hz (Predicate: AC 110V-230V/50-60Hz) |
| Dimension & Weight | Not raising safety/effectiveness issues despite difference | 460 x 425 x 1120mm, 52Kg (Predicate: 560 x 380 x 1180mm, 60Kg) |
| Patient Contact Material | Biocompatibility tested per ISO 10993 series | Photoconductive crystals (Handpiece), ABS (Handpiece Shell). (Predicate: Sapphire (Handpiece), Unknown (Handpiece Shell)) |
| Biocompatibility (Cytotoxicity) | No Cytotoxicity | No Cytotoxicity |
| Biocompatibility (Sensitization) | No evidence of Sensitization | No evidence of Sensitization |
| Biocompatibility (Irritation) | No evidence of Irritation | No evidence of Irritation |
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-2-22, IEC 60825 | Complies |
| EMC | Comply with IEC 60601-1-2 | Complies |
| Accuracy Testing | Energy output and spot size do not deviate tolerance of setting. | Testing conducted, assumed compliance based on no negative findings. |
| Software Verification & Validation | "Major" level of concern. Documentation provided per FDA guidance. | Testing conducted, assumed compliance. |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not applicable in the context of clinical performance testing for a device like this. The "test set" primarily refers to the device itself and its components undergoing non-clinical bench testing.
- Data provenance: The testing was non-clinical (bench testing, electrical safety, biocompatibility, software V&V). The document does not specify geographic origin for these tests. It states "No clinical study is included in this submission" (Page 6).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical study or human reader interpretation for ground truth was performed or required for this 510(k) submission. Ground truth for non-clinical tests would be established by standard measurement equipment and lab protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human reader interpretation or adjudication of medical images/data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this refers to an AI/ML algorithm. This device is a laser hair removal machine, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is based on engineering specifications, direct measurements of physical properties (e.g., wavelength, power output, dimensions), and established laboratory testing standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety). There is no "pathology" or "outcomes data" in this context as no clinical study was conducted.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, this is not an AI/ML device.
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